Assisted cutting balloon

ABSTRACT

A dilation balloon is wrapped in one or more patterns with a wire or braided material having diamond abrasive or other abrasive material bonded thereto. The wire or braided material is vibrated in one or more ways to enhance the cutting action of the wire abrasive. The wire abrasive may be vibrated using high, low, or even ultrasonic waves transmitted to the wire abrasive via local or remote methods. Alternatively, the dilation balloon may be dilated with a contrast media that exhibits a high absorption to laser light. The contrast material is lased with a laser fiber or fibers inserted into the balloon interior, creating a substantial shockwave that vibrates the balloon and assists in the cracking or abrading of the surrounding plaque in contact with the dilation balloon. The cutting balloon may employ the abrasive coated wires described above or cutting blades.

FIELD

This disclosure relates generally to cutting balloons utilized inballoon angioplasty and particularly to cutting balloons whose cuttingaction is assisted in one or more ways to increase the cutting actionwhile at the same time allowing for reduced pressure within the cuttingballoon.

BACKGROUND

Coronary artery disease (CAD) affects millions of Americans, making itthe most common form of heart disease. CAD most often results from acondition known as atherosclerosis, wherein a waxy substance formsinside the arteries that supply blood to the heart. This substance,called plaque, is made of cholesterol, fatty compounds, calcium, and ablood-clotting material called fibrin. As the plaque builds up, theartery narrows, making it more difficult for blood to flow to the heart.As the blockage gets worse, blood flow to the heart slows, and acondition called angina pectoris, or simply angina, may develop. Anginais like a squeezing, suffocating, or burning feeling in the chest. Thepain usually happens when the heart has an extra demand for blood, suchas during exercise or times of emotional stress. In time, the narrowedor blocked artery can lead to a heart attack. A number of medicines canbe used to relieve the angina pain that comes with CAD, but thesemedicines cannot clear blocked arteries. A moderate to severely narrowedcoronary artery may need more aggressive treatment to reduce the risk ofa heart attack.

Balloon angioplasty is a technique for mechanically widening narrowed orobstructed arteries, the latter typically being a result ofatherosclerosis. An empty and collapsed balloon on a guide wire, knownas a balloon catheter, is passed into the narrowed locations and theninflated to a fixed size using water pressures some 75 to 500 timesnormal blood pressure (6 to 20 atmospheres). The balloon is carefullyinflated, first under low pressure, and then under higher pressure,until the narrowed area is widened. The balloon inflation crushes thefatty deposits it expands against, opening up the blood vessel forimproved blood flow. The balloon is then deflated and withdrawn.Although the narrowing is improved in a majority of patients followingballoon dilation, over time, the artery can again become narrow in asmany as 15% to 20% of cases, requiring further balloon dilation. A stentmay or may not be inserted at the time of balloon dilation to ensure thevessel remains open.

Percutaneous coronary intervention (PCI) is a therapeutic procedure totreat the stenotic (narrowed) coronary arteries of the heart due to CAD.These stenotic segments are caused by the buildup of plaque that formsdue to atherosclerosis. PCI is usually performed by an interventionalcardiologist.

PCI includes the use of balloons, stents, and atherectomy devices. PCIis accomplished with a small balloon catheter inserted into an artery inthe groin or arm, and advanced to the narrowing in the coronary artery.The balloon is then inflated to enlarge the narrowing in the artery.When successful, PCI allows more blood and oxygen to be delivered to theheart muscle and can relieve the chest pain of angina, improve theprognosis of individuals with unstable angina, and minimize or stop aheart attack without having the patient undergo open heart coronaryartery bypass graft (CABG) surgery.

Balloon angioplasty is also called percutaneous transluminal coronaryangioplasty (PTCA). Both PCI and PTCA are non-surgical procedures.Balloon angioplasty can also be used to open narrowed vessels in manyother parts of the body. Peripheral angioplasty (PA) refers to the useof a balloon to open a blood vessel outside the coronary arteries. It iscommonly done to treat atherosclerotic narrowing of the abdomen, leg,and renal arteries. PA can also be done to treat narrowing in veins.Often, PA is used in conjunction with peripheral stenting andatherectomy. For example, doctors can perform carotid angioplasty toopen narrowed carotid arteries, which are the arteries that supply bloodto the brain. A stroke most often occurs when the carotid arteriesbecome blocked and the brain does not get enough oxygen. Balloonangioplasty can also be performed in the aorta (the main artery thatcomes from the heart), the iliac artery (in the hip), the femoral artery(in the thigh), the popliteal artery (behind the knee), and the tibialand peroneal arteries (in the lower leg). The use of fluoroscopy assiststhe doctor in the location of blockages in the coronary arteries as thecontrast dye moves through the arteries. A small sample of heart tissue(biopsy) may be obtained during the procedure to be examined later underthe microscope for abnormalities.

A cutting balloon (CB) is an angioplasty device used in PCI and PTCA andis a proven tool for the mechanical challenges of complex lesions thatare often resistant to conventional balloon angioplasty. A CB has aspecial balloon with small blades that are activated when the balloon isinflated. The CB typically has three or four atherotomes (microsurgicalblades) bonded longitudinally to its surface, suitable for creatingdiscrete longitudinal incisions in the atherosclerotic target coronarysegment during balloon inflation. Cutting balloon angioplasty (CBA)features three or four atherotomes, which are 3-5 times sharper thanconventional surgical blades. The atherotomes, which are fixedlongitudinally on the outer surface of a non-complaint balloon, expandradially and deliver longitudinal incisions in the plaque or targetlesion, relieving its hoop stress. With the CBA, the increase in thevessel lumen diameter is obtained in a more controlled fashion and witha lower balloon inflation pressure than PCI and PTCA proceduresutilizing conventional balloons. This controlled dilation could reducethe extent of vessel wall injury and the incidence of restenosis.

The advantage of CBA is its ability to reduce vessel stretch and vesselinjury by scoring the target coronary segment longitudinally rather thancausing an uncontrolled disruption of the atherosclerotic plaque ortarget lesion. The atherotomes deliver a controlled fault line duringdilation to ensure that the crack propagation ensues in an orderlyfashion. The CB also dilates the target vessel with less force todecrease the risk of a neoproliferative response and restenosis. Theunique design of the CB is engineered to protect the vessel from theedges of the atherotomes when it is deflated. This minimizes the risk oftrauma to the vessel as the balloon is passed to and from the targetcoronary segment. With CBA, balloon inflation pressures can still rangebetween 14-16 atmospheres, though lower inflation pressures arerecommended.

Angioplasty balloons that employ a woven mesh, cutting strings, or wiresare also known in the art. These balloons have been shown to be moreflexible and safer than balloons employing cutting blades and edges. Thescoring elements can, for example, be in the form of a single wire or aplurality of wires wrapped around a dilation balloon in a helicalconfiguration. Other angioplasty cutting balloon catheter assemblieshave a catheter equipped with an inflatable balloon with an interiorcavity and an expandable covering around the balloon. The expandablecovering may be in the form of a mesh coating having a cross-hatchedpattern. The mesh coating may be made of plastic or metal fibers, whereat least some of the fibers have cutting edges. In operation, thecutting edges abrade the stenosis, plaque, or lesions along the vesselwalls when the catheter assembly is reciprocally moved longitudinally orrotationally after inflation of the balloon.

SUMMARY

These and other needs are addressed by the various aspects, embodiments,and configurations of the present disclosure. The disclosure isgenerally directed to the use of vibrations to enhance the performanceof cutting balloons, particularly in angioplasty, in treating lesions,occlusions and plaque.

A method, according to this disclosure, can perform balloon angioplastyby the steps of:

(a) inserting an assisted cutting balloon into a target coronary segmentpartially occluded with plaque, the assisted cutting balloon having oneor more cutting devices positioned on an exterior of the dilationballoon; and

(b) inflating the dilation balloon and vibrating the one or more cuttingdevices while the cutting balloon is inserted into the target coronarysegment.

The expanding and vibrating dilation balloon can crush softer portionsof the plaque, and/or the vibrating wire abrasive can cut the harder orcalcified portions of the plaque.

An assisted cutting balloon for performing balloon angioplasty,according to this disclosure, can include:

(a) a dilation balloon;

(b) one or more cutting devices operably positioned on an exterior ofthe dilation balloon;

(c) a laser light source terminating at a distal end in the interior ofthe dilation balloon; and

(d) a contrast medium for inflating the dilation balloon.

As the dilation balloon is inflated with the contrast medium and/orafter inflation, the laser light source can transmit pulsed laser lightinto the contrast medium creating shockwaves that propagate through thecontrast medium, thereby causing the cutting device(s) to vibrate andassist in the cracking or abrading of the surrounding plaque in contactwith the balloon.

The contrast material commonly exhibits a high degree of opticalabsorption to the laser light. When a laser fiber or fibers insertedinto the balloon interior emit optical energy into the contrastmaterial, the material is believed to experience a rapid rate of energyabsorption, creating the shockwave.

An assisted cutting balloon for performing balloon angioplasty,according to this disclosure, can include:

(a) a dilation balloon;

(b) one or more cutting devices operably positioned on an exterior ofthe dilation balloon; and

(c) a flexible wire waveguide connected at a distal end to the cuttingdevice(s) and at a proximal end to an ultrasonic apparatus.

The ultrasonic apparatus can transmit ultrasonic waves through theflexible wire waveguide to the cutting device(s) causing the cuttingdevice(s) to vibrate as and/or after the dilation balloon is inflated,thereby assisting in the cracking or abrading of the surrounding plaquein contact with the balloon.

The cutting device(s) can be a wire abrasive bound to an exterior of thedilation balloon.

In one application, wire or braid material is constructed with a diamondabrasive or other types of abrasive cutting material and is wrappedaround a dilation balloon in a helical or other type of configuration.The wire or braided material is vibrated using high, low, or evenultrasonic waves transmitted to the wire or braided material via localor remote methods, substantially enhancing the ability to cut or abradethe plaque.

The guide wire can be inserted into a vasculature system and moved pastthe target coronary segment, and the assisted cutting balloon translatedover the guide wire to the target coronary segment.

In one procedure, the dilation balloon can be inflated with a contrastmedium. Specifically, a laser fiber and the assisted cutting balloon aretranslated along over the guide wire to the target coronary segment,with the distal end of the laser fiber terminating in the middle of thedilation balloon. A laser generator connected to a proximal end of thelaser fiber emits laser light from the distal end of the laser fiber ata very short pulse duration, thereby creating shockwaves that propagatethrough the contrast medium as the dilation balloon is inflating,causing the cutting device(s) to vibrate. The vibrations cause thecutting device(s) to cut or abrade harder or calcified portions of theplaque as the dilation balloon is inflating. The laser generatortypically generates 308 nm laser light at pulse durations ranging from120-140 nsec. While other types of laser generators can be employed, acommon laser generator is an excimer laser.

To assist positioning within the body, the assisted cutting balloon,guide wire, and laser fiber can be enclosed in a multi-lumen catheter.

In another procedure, an ultrasonic apparatus having a flexible wirewaveguide connected at a proximal end to the ultrasonic apparatus andconnected at a distal end to the cutting device(s) transmits ultrasonicwaves through the flexible wire waveguide to the cutting device(s),causing the cutting device(s) to vibrate. The vibrating cuttingdevice(s) cut the harder or calcified portions of the plaque as and/orafter the dilation balloon is inflated.

In any of the above procedures, the balloon is commonly inflated topressures ranging between about 1-30 atmospheres, 5-25 atmospheres, and10-20 atmospheres.

The present disclosure can provide benefits relative to conventionalcutting balloons. The use of vibration, at low, medium, or highfrequencies, can enhance dramatically the performance of cuttingballoons. Cutting device(s), particularly the wire or braid materialsconstructed with diamond abrasives or other type of abrasive cuttingmaterials, can cut, abrade, or otherwise modify plaque, particularlycalcified or hard plaque, while leaving surrounding soft tissue andcompliant balloon material substantially unaltered and undamaged. Thiscan be a very effective method to assist in cracking or modifying plaquein arteries. The disclosure can avoid the need to inflate balloons tovery high pressures (e.g., from about 15 to about 30 atms), therebypermitting the use of lower pressures (e.g., typically no more thanabout 10 atms and even more typically no more than about 7.5 atms).

As used herein, “at least one,” “one or more,” and “and/or” areopen-ended expressions that are both conjunctive and disjunctive inoperation. For example, each of the expressions “at least one of A, Band C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “oneor more of A, B, or C,” and “A, B, and/or C” means A alone, B alone, Calone, A and B together, A and C together, B and C together, or A, B andC together. When each one of A, B, and C in the above expressions refersto an element, such as X, Y, and Z, or class of elements, such as X1-Xm,Y1-Yn, and Z1-Zo, the phrase is intended to refer to a single elementselected from X, Y, and Z, a combination of elements selected from thesame class (e.g., X1 and X2) as well as a combination of elementsselected from two or more classes (e.g., Y1 and Z3).

It is to be noted that the term “a” or “an” entity refers to one or moreof that entity. As such, the terms “a” (or “an”), “one or more,” and “atleast one” can be used interchangeably herein. It is also to be notedthat the terms “comprising,” “including,” and “having” can be usedinterchangeably.

“Contrast medium” or “contrast media” is generally any substance used tochange the imaging characteristics of a patient, thereby providingadditional information such as anatomical, morphological, and/orphysiological. Contrast media can, for example, provide informationregarding vasculature, vascular integrity, and/or qualitative assessmentof vasculature function or operation. Positive contrast agents increasethe attenuation of tissue, blood, urine, or outline spaces such as thegastrointestinal lumen or subarachnoid space. Two primary types ofpositive contrast agents are barium sulfate agents and varioushalogenated (e.g., iodated) compounds. Negative contrast agents normallydecrease attenuation by occupying a space, such as the bladder,gastrointestinal tract, or blood vessels. Negative contrast agents aretypically gases, such as carbon dioxide and nitrous oxide. Another typeof contrast media, namely MRI contrast agents, uses typicallysuperparamegnetism. Finally, ultrasound contrast media, namelysonagraphic contrast agents, are typically composed of gas bubbles (airor perfluor gases) stabilized by a shell of phospholipids, surfactants,albumin, or polymers.

The term “means” as used herein shall be given its broadest possibleinterpretation in accordance with 35 U.S.C., Section 112, Paragraph 6.Accordingly, a claim incorporating the term “means” shall cover allstructures, materials, or acts set forth herein, and all of theequivalents thereof. Further, the structures, materials or acts and theequivalents thereof, shall include all those described in the summary ofthe invention, brief description of the drawings, detailed description,abstract, and claims themselves.

“Ultrasound” refers to sound or other vibrations having an ultrasonicfrequency, which is commonly a frequency above about 20 thousand cyclesper second (20,000 Hz).

It should be understood that every maximum numerical limitation giventhroughout this disclosure is deemed to include each and every lowernumerical limitation as an alternative, as if such lower numericallimitations were expressly written herein. Every minimum numericallimitation given throughout this disclosure is deemed to include eachand every higher numerical limitation as an alternative, as if suchhigher numerical limitations were expressly written herein. Everynumerical range given throughout this disclosure is deemed to includeeach and every narrower numerical range that falls within such broadernumerical range, as if such narrower numerical ranges were all expresslywritten herein.

The preceding is a simplified summary of the disclosure to provide anunderstanding of some aspects of the disclosure. This summary is neitheran extensive nor exhaustive overview of the disclosure and its variousaspects, embodiments, and configurations. It is intended neither toidentify key or critical elements of the disclosure nor to delineate thescope of the disclosure but to present selected concepts of thedisclosure in a simplified form as an introduction to the more detaileddescription presented below. As will be appreciated, other aspects,embodiments, and configurations of the disclosure are possible,utilizing alone or in combination, one or more of the features set forthabove or described in detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic illustration of an embodiment of an assistedcutting balloon.

FIG. 2 shows a schematic diagram of an embodiment of an ultrasonicgenerator apparatus.

FIG. 3 shows a partial cross section view of a partially occluded arterywith an assisted cutting balloon in place prior to inflation.

FIG. 4 shows a partial cross section view of a partially occluded arterywith an assisted cutting balloon in place and inflated.

FIG. 5 shows a partial cross section view of a partially occluded arterywith an assisted cutting balloon after deflation and ready for removal.

FIG. 6 shows a schematic illustration of another embodiment of anassisted cutting balloon.

FIG. 7 shows a schematic diagram of an embodiment of a laser generatorapparatus.

The accompanying drawings are incorporated into and form a part of thespecification to illustrate several examples of the present disclosure.These drawings, together with the description, explain the principles ofthe disclosure. The drawings simply illustrate preferred and alternativeexamples of how the disclosure can be made and used and are not to beconstrued as limiting the disclosure to only the illustrated anddescribed examples. Further features and advantages will become apparentfrom the following, more detailed, description of the various aspects,embodiments, and configurations of the disclosure, as illustrated by thedrawings referenced below.

DETAILED DESCRIPTION

FIG. 1 shows a schematic illustration of an embodiment of an assistedcutting balloon. Referring now to FIG. 1, Assisted Cutting Balloon 10includes a Dilation Balloon 12, which may be any conventionalangioplasty balloon such as commonly used by interventionalcardiologists or radiologists, and a Wire Abrasive 14 mounted, attached,affixed, or otherwise bound, in a helical configuration, to the exteriorof Dilation Balloon 12. Wire Abrasive 14 may be one wire strand or manywire strands wrapped or braided together. The wire may be composed ofany suitable material, with one or more metal and/or plastic fibersbeing typical. Diamond material or any other suitable abrasives may beused as an abrasive bonded to the wire. Diamond wire impregnated withdiamond dust is relatively inexpensive and is readily available invarious diameters and lengths. Multiple configurations of DilationBalloon 12 may be used with different types of cutting wire or stringwrap patterns or braids, such as diamond, cross-hatch, woven or unwovenmesh, reverse helical, longitudinal, radial, etc., around the exteriorof the Dilation Balloon 12 and with different types of abrasive coatedwire or cutting blades or atherotomes in a variety of geometrical shapesbonded or applied to Dilation Balloon 12. Other cutting balloonconfigurations known to those of skill in the art may be employed as theDilation Balloon 12. Guide Wire 30 is inserted into the vasculaturesystem of the subject and past Target Coronary Segment 32 (see FIG. 3).Assisted Cutting Balloon 10 is translated over Guide Wire 30 to TargetCoronary Segment 32.

FIG. 2 shows a schematic diagram of an embodiment of an ultrasonicgenerator apparatus. Referring now to FIG. 2, Ultrasonic Apparatus 16includes a Piezoelectric Converter And Acoustic Horn 18 that operateswith a resonant frequency. Piezoelectric Converter And Acoustic Horn 18is driven by Ultrasonic Generator 20 at an adjustable resonant frequencyor set of plural frequencies. The frequencies can be temporally fixed orvaried during Assisted Cutting Balloon 12 operation. This ensures thatresonance of Piezoelectric Converter And Acoustic Horn 18 is achieveddespite minor alterations in the resonant frequency of the system. Inaddition, Ultrasonic Generator 20 has adjustable input power dialsettings.

Flexible Wire Waveguide 22 is connected to Piezoelectric Converter AndAcoustic Horn 18 at a Proximal End 24 and fixed tightly into theradiating face of Piezoelectric Converter And Acoustic Horn 18 ensuringa rigid connection between the two. Distal End 26 of Flexible WireWaveguide 22 is rigidly connected to a Proximal End 28 of Wire Abrasive14 (see FIG. 1). Other local or remote methods may be used to transmithigh, low, or ultrasonic waves to Flexible Wire Waveguide 22 such as.

FIG. 3 shows a partial cross section view of a partially occluded arterywith an assisted cutting balloon in place prior to inflation. Referringnow to FIG. 3, Assisted Cutting Balloon 10 has been translated overGuide Wire 30 to Target Coronary Segment 32. The interior of Artery 34is partially occluded with deposits of Plaque 36.

FIG. 4 shows a partial cross section view of a partially occluded arterywith an assisted cutting balloon in place and inflated. Referring now toFIG. 4, as Dilation Balloon 12 is inflated, Ultrasonic Apparatus 16 ispowered on. Flexible Wire Waveguide 22 causes Wire Abrasive 14 tovibrate. Thus, as Wire Abrasive 14 of Dilation Balloon 12 comes intocontact with Plaque 36, Dilation Balloon 12 crushes the softer portionsof Plaque 36 and the cutting action of Wire Abrasive 14, which isenhanced due to the vibration imparted via Flexible Wire Waveguide 22,cuts the harder or calcified portions of Plaque 36. The enhanced cuttingaction reduces the inflation pressure necessary to 5 to 10 atmosphereswhich reduces the chance for damage to Artery 34.

FIG. 5 shows a partial cross section view of a partially occluded arterywith an assisted cutting balloon after deflation and ready for removal.Referring now to FIG. 5, Striations 38 can be seen in crushed Plaque 36due to the cutting action of Wire Abrasive 14. Assisted Cutting Balloon10 is now ready for removal over Guide Wire 30.

FIG. 6 shows a schematic illustration of another embodiment of anassisted cutting balloon. Referring now to FIG. 6, Assisted CuttingBalloon 50 includes a Dilation Balloon 52, which may be any conventionalangioplasty balloon such as commonly used by interventionalcardiologists or radiologists, and a Wire Abrasive 54 mounted over orattached to Dilation Balloon 52. Wire Abrasive 54 may be one wire strandor many wire strands braided together. Diamond material or any othersuitable abrasives may be used as an abrasive bonded to the wire.Diamond wire impregnated with diamond dust is relatively inexpensive andis readily available in various diameters and lengths. Multipleconfigurations of Dilation Balloon 52 may be used with different typesof wire wrap patterns or braids, such as diamond or cross-hatch,helical, etc., and with different types of abrasive coated wire orcutting blades in a variety of geometrical shapes bonded or applied toDilation Balloon 12. Guide Wire 70 is inserted into the subject andAssisted Cutting Balloon 50 is translated over Guide Wire 70 to a targetcoronary segment, such as Target Coronary Segment 32 shown in FIG. 3.

FIG. 7 shows a schematic diagram of an embodiment of a laser generatorapparatus. Referring now to FIG. 7, a laser light source such as LaserApparatus 56 includes a Laser Generator 58 controlled by a Computer 60.Flexible Cladding 62 shields Laser Fiber 64, which may be a single fiberor multiple fibers. Flexible Cladding 62 runs parallel with Guide Wire70 and both may be enclosed in a multi-lumen catheter along withAssisted Cutting Balloon 10. Distal End 66 (see FIG. 6) of FlexibleCladding 62 terminates in the middle of Dilation Balloon 52. Laser Fiber64 extends a short distance from Distal End 66. When Assisted CuttingBalloon 50 has been translated over Guide Wire 70 to a target coronarysegment, it will appear like that shown in FIG. 3, where the interior ofArtery 34 of Target Coronary Segment 32 is partially occluded withdeposits of Plaque 36.

Substituting now Assisted Cutting Balloon 50 for Assisted CuttingBalloon 10 shown in FIG. 4, Dilation Balloon 52 is inflated withContrast Medium 68. Contrast Medium 68 may be one of many differentcompounds as found in the ACR Manual of Contrast Media, Version 8, 2012.As Dilation Balloon 52 is inflated, Laser Apparatus 56 is activated,which, in one embodiment, may be an excimer laser that emits 308 nmlaser light at very short pulse durations (120-140 nsec.) from LaserFiber 64. Contrast Medium 68 exhibits a very high absorption to thislaser light. Due to the high absorption and short pulse width of thelaser light, shockwaves are created that propagate through the volume ofContrast Medium 68 within Dilation Balloon 52. The shockwaves assist inthe cracking, crushing, or modification of Plaque 36 by Dilation Balloon52. The shockwave also causes Wire Abrasive 54 to vibrate. Thus, as WireAbrasive 54 of Dilation Balloon 52 comes into contact with Plaque 36,Dilation Balloon 52, assisted by the shockwaves as well as by inflation,crushes the softer portions of Plaque 36, and the cutting action of WireAbrasive 54, which is enhanced due to the vibration imparted via theshockwaves traveling through the volume of Contrast Medium 68, cuts theharder or calcified portions of Plaque 36. Dilation Balloon 52 is thendeflated and ready for removal as shown in FIG. 5. Striations 38 willalso be seen in crushed Plaque 36 due to the cutting action of WireAbrasive 54.

A number of variations and modifications of the disclosure can be used.It would be possible to provide for some features of the disclosurewithout providing others.

For example in one alternative embodiment, cutting blades may be usedinstead of abrasive wire.

In another example, other Assisted Cutting Balloon 12 vibratingmechanisms may be employed. Examples include mechanically inducedvibration (e.g., by a micro-vibration motor), electrically inducedvibration, electromechanically induced vibration (e.g., by amicro-electromechanical system), magnetically induced vibration,electromagnetically induced vibration, and vibration induced by othersound or acoustical frequencies.

In another example, the vibration source may be positioned eitherremotely, as discussed and shown above, or locally, such as in theproximity of the balloon itself, or a combination thereof.Micro-components can be positioned in or near the balloon in thecatheter itself whereby attenuation of vibrations remotely generated isreduced. For example, a micro-vibration motor, micro-electromechanicalsystem, or micro-piezoelectric transducer can be positioned in thecatheter in proximity to the balloon.

The present disclosure, in various aspects, embodiments, andconfigurations, includes components, methods, processes, systems and/orapparatus substantially as depicted and described herein, includingvarious aspects, embodiments, configurations, subcombinations, andsubsets thereof. Those of skill in the art will understand how to makeand use the various aspects, embodiments, and configurations, afterunderstanding the present disclosure. The present disclosure, in variousaspects, embodiments, and configurations, includes providing devices andprocesses in the absence of items not depicted and/or described hereinor in various aspects, embodiments, and configurations hereof, includingin the absence of such items as may have been used in previous devicesor processes, e.g., for improving performance, achieving ease and\orreducing cost of implementation.

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the disclosure to the form or forms disclosed herein. Forexample, in the foregoing Detailed Description, various features of thedisclosure are grouped together in one or more, aspects, embodiments,and configurations for the purpose of streamlining the disclosure. Thefeatures of the aspects, embodiments, and configurations of thedisclosure may be combined in alternate aspects, embodiments, andconfigurations other than those discussed above. This method ofdisclosure is not to be interpreted as reflecting an intention that theclaimed disclosure requires more features than are expressly recited ineach claim. Rather, as the following claims reflect, inventive aspectslie in less than all features of a single foregoing disclosed aspects,embodiments, and configurations. Thus, the following claims are herebyincorporated into this Detailed Description, with each claim standing onits own as a separate preferred embodiment of the disclosure.

Moreover, though the description of the disclosure has includeddescriptions of one or more aspects, embodiments, or configurations andcertain variations and modifications, other variations, combinations,and modifications are within the scope of the disclosure, e.g., as maybe within the skill and knowledge of those in the art, afterunderstanding the present disclosure. It is intended to obtain rightswhich include alternative aspects, embodiments, and configurations tothe extent permitted, including alternate, interchangeable and/orequivalent structures, functions, ranges or steps to those claimed,whether or not such alternate, interchangeable and/or equivalentstructures, functions, ranges or steps are disclosed herein, and withoutintending to publicly dedicate any patentable subject matter.

What is claimed is:
 1. A method for performing balloon angioplasty, themethod comprising the steps of: (a) inserting an assisted cuttingballoon into a target coronary segment partially occluded with plaque,the assisted cutting balloon having a dilation balloon with one or morecutting devices operably positioned on an exterior of the dilationballoon; (b) vibrating the one or more cutting devices; and (c)inflating the dilation balloon; whereby the expanding dilation ballooncrushes the softer portions of the plaque and the vibrating one or morecutting devices cuts the harder or calcified portions of the plaque. 2.The method according to claim 1, wherein the one or more cutting devicescomprise one or more wire abrasives bound to the exterior of thedilation balloon and wherein step (a) further comprises the steps of:inserting a guide wire into a vasculature system and past the targetcoronary segment; and translating the assisted cutting balloon over theguide wire to the target coronary segment.
 3. The method according toclaim 2, wherein step (c) further comprises the step of: inflating thedilation balloon with a contrast medium.
 4. The method according toclaim 3, further comprising the steps of: translating a laser fiberalong with the assisted cutting balloon over the guide wire to thetarget coronary segment, the distal end of the laser fiber terminatingin the middle of the dilation balloon; powering on a laser generatorconnected to a proximal end of the laser fiber; emitting laser lightfrom the distal end of the laser fiber at very short pulse durationscreating shockwaves that propagate through the contrast medium as thedilation balloon is inflating, causing the wire abrasive to vibrate; andcutting by the wire abrasive as it vibrates the harder or calcifiedportions of the plaque as the dilation balloon is inflating.
 5. Themethod according to claim 4, wherein the translating step furthercomprises the step of: enclosing the assisted cutting balloon, the guidewire, and the laser fiber into a multi-lumen catheter.
 6. The methodaccording to claim 4, wherein the emitting step further comprises thestep of: generating, by the laser generator, 308 nm laser light at pulsedurations ranging from 120-140 nsec that are emitted from the distal endof the laser fiber, wherein the laser generator is an excimer laser. 7.The method according to claim 4, further comprising the step of:assisting the crushing of the softer portions of the plaque by theshockwaves propagating within the dilation balloon.
 8. The methodaccording to claim 1, wherein step (b) further comprises the steps of:powering on an ultrasonic apparatus having a flexible wire waveguideconnected at a proximal end to the ultrasonic apparatus, and connectedat a distal end to the one or more cutting devices; transmittingultrasonic waves from the ultrasonic apparatus through the flexible wirewaveguide to the one or more cutting devices, causing the one or morecutting devices to vibrate; and cutting by the one or more cuttingdevices as it vibrates the harder or calcified portions of the plaque asthe dilation balloon is inflated.
 9. The method according to claim 1wherein step (c) further comprises the step of: inflating the dilationballoon to a pressure ranging between 5 to 10 atmospheres.
 10. Anassisted cutting balloon for performing balloon angioplasty comprising:a dilation balloon; one or more cutting devices operably positioned onan exterior of the dilation balloon; and a flexible wire waveguideconnected at a distal end to the one or more cutting devices andconnected at a proximal end to an ultrasonic apparatus; whereby theultrasonic apparatus transmits ultrasonic waves through the flexiblewire waveguide to the one or more cutting devices causing the one ormore cutting devices to vibrate as and/or after the dilation balloon isinflated.
 11. The assisted cutting balloon for performing balloonangioplasty according to claim 10, wherein the one or more cuttingdevices comprise a wire abrasive bound to an exterior of the dilationballoon and further comprising: a guide wire for translating theassisted cutting balloon to a target coronary segment partially occludedwith plaque, wherein the guide wire is inserted into a vasculaturesystem and past the target coronary segment.
 12. The assisted cuttingballoon for performing balloon angioplasty according to claim 10,wherein the one or more cutting device during vibration cuts the harderor calcified portions of the plaque as the dilation balloon is inflated.13. The assisted cutting balloon for performing balloon angioplastyaccording to claim 10, wherein the dilation balloon is inflated to apressure ranging between 5 to 10 atmospheres.
 14. The assisted cuttingballoon for performing balloon angioplasty according to claim 11,wherein the wire abrasive is diamond dust, and the wire wrap pattern ofthe wire abrasive bound to the dilation balloon is one or more ofdiamond, cross-hatch, mesh, longitudinal, radial, and helical.
 15. Anassisted cutting balloon for performing balloon angioplasty comprising:a dilation balloon; one or more cutting devices operably positioned onan exterior of the dilation balloon; a laser light source terminating ata distal end in the interior of the dilation balloon; and a contrastmedium for inflating the dilation balloon; whereby, as and/or after thedilation balloon is inflated with the contrast medium, the laser lightsource transmits pulsed laser light into the contrast medium creatingshockwaves that propagate through the contrast medium causing the one ormore cutting devices to vibrate.
 16. The assisted cutting balloon forperforming balloon angioplasty according to claim 15, wherein the one ormore cutting devices comprise a wire abrasive bound to the exterior ofthe dilation balloon and further comprising: a guide wire fortranslating the assisted cutting balloon and the laser light source to atarget coronary segment partially occluded with plaque, wherein theguide wire is inserted into a vasculature system and past the targetcoronary segment.
 17. The assisted cutting balloon for performingballoon angioplasty according to claim 15, wherein the laser lightsource further comprises: a laser fiber translated along with theassisted cutting balloon to the target coronary segment; a lasergenerator connected to a proximal end of the laser fiber and the distalend of the laser fiber terminates in the middle of the dilation balloon;and a laser light emitted from the distal end of the laser fiber at veryshort pulse durations creating shockwaves that propagate through thecontrast medium as the dilation balloon is inflating, causing the one ormore cutting devices to vibrate, wherein, as the dilation balloon isinflated, the one or more cutting devices vibrate and cut harder orcalcified portions of the plaque.
 18. The assisted cutting balloon forperforming balloon angioplasty according to claim 17, furthercomprising: a multi-lumen catheter for enclosing the assisted cuttingballoon, the guide wire, and the laser fiber.
 19. The assisted cuttingballoon for performing balloon angioplasty according to claim 15,wherein the laser light source is an excimer laser that generates 308 nmlaser light at pulse durations ranging from 120-140 nsec.
 20. Theassisted cutting balloon for performing balloon angioplasty according toclaim 16, wherein the wire abrasive is diamond dust, and the wire wrappattern of the wire abrasive bound to the dilation balloon is one ormore of diamond, cross-hatch, mesh, longitudinal, radial, and helical.